Friday, 23 June 2017

#NewsSpeak: another eagle has landed only this time it is a maven

Oral cladribine finally gets licensed for the treatment of relapsing MS #NewsSpeak #MavenCladI was invited to a meeting to advice Serono in 2002 whether, or not, they should in-license an oral formulation of cladribine. We advised yes and today the CHMP have recommended that the EU give Merck a marketing authorisation for oral cladribine. The process took 15 years. Who said MS drug development was fast? The oral formulation of cladribine, Mavenclad, is the first oral selective immune reconstitution therapy (SIRT)* for treating patients with active relapsing MS. *Please note SIRT is a new term to describe the class of drugs that work via immune depletion, which can be non-selective or selective, followed by immune reconstitution.

Angry of Tunbridge is happy. It's because of my badgering that Team G finally got their act together and started publishing decent research papers and helping get agents to the patient. So well done Team G. Unlike you Mouse I don't touch alcohol (Devil's brew). Keep up the good work.

A big reason for the delay was development was stopped in 2011 by Merck Serono because of a cancer risk, which was subsequently identified by Dr K and team as erroneous in 2015 https://www.ncbi.nlm.nih.gov/pubmed/26468472 this led to Movectro's reactivation and resubmission to the EMA and now approval.I hope Merck Serono will be showing their appreciation ;-)

First they had to work out how to take a drug that is active in MS and turn it into a drug that is active in MS and has a patent attached to it.

In this case they took generic cladribine that is active via the intravenous or subcutaneous route and spend a few hundred million making it into an oral version so you can take a few pills a year rather than a few 10 second injections.

Do the toxicology and do a thousand peorson trial. This was done and dusted before 2010.. So then you go on a 7 year holiday urinating money away from lost sales.

Who is that person/organization with God's powers who decides that some hundreds/thousands of people will not be on the DMD which may work the best for them for 7 years?

While there are other DMDs for pwRRMS, a similar story applies to ocrelizumab, where there is no alternative for pwPPMS. The system is broken.

Let's assume that someone finds the cure for MS next month. Will we have to wait another 15 years till we have access to it? And till that time, are we going to see ourselves lose the ability to walk, hand function, etc etc?

This is awesome! So is that paper... My favourite bit, is the bit that says "The authors are grateful to Barts Charity for funding to cover publication costs".Have to admit, it is pretty cool to be treated in a healthcare system where our national academics have got 2 excellent treatments licensed to treat this historically intractable condition in less than a decade! Huge thumbs up to British research!

Just got home from a very long day and was reflecting on the EMA's decision and the whole drawn out process of getting Clad to market. I am feeling a bit flat and let down. Why? Mavenclad should have the same license as alemtuzumab, i.e. we should be able to offer it patients with active relapsing-forms of MS.

I can already see the perverse scenario emerging in which a patient wants an IRT (immune reconstitution therapy) and has active, but not highly active, MS and all that we can offer is alemtuzumab in the class. C'est la vie?

Gavin I note Fred Lublin referred to you last night as an 'inductionist', it sounds much cooler than an SIRTist. The latter sounds like and itch in a place you don't want to discuss ;)

***

P.S. Congratulations and don't be too disappointed, when you take a broader perspective cladribine got there against all the odds. I am looking forward to being able prescribe it myself without having to refer my patients East.

1. adjectiveIf someone describes a young woman as pert, they mean that they like her because she is lively and not afraid to say what she thinks. This use could cause offence....a pert redhead in uniform....pert replies by servant girls.2. adjectiveIf you say that someone has, for example, a pert bottom or nose, you mean that it is quite small and neat, and you think it is attractive.[approval]But there is more to Charles than his pert bottom and hairy chest....the tiny drops of rain gleaming on her wide forehead and her pert nose.

I want treatment for all, if you are EDSS 6.5 you will still have no option unless one goes off-label. I think todays announce vindicates the stance of DrK that this is not a second rate treatment option

I dont know i will let G answer.The difference.... a few thousand pounds...they will charge more for a second line than they would had it been first line and greater sales i suspect. It is in the space of natalizumab

There is a long history of cladribine use in hairy cell leucemia and this is not an issue, but never say never. Cladribine does not seem to deplete CD8 cells much. Using a dose adapted approach based on lymphocyte numbers we don't have grade 3/4 lmyphopenia.

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